Senators Want FDA to Regulate Compounders

by David Pittman David Pittman Washington Correspondent, MedPage Today
November 15, 2012

WASHINGTON -- Senators from both political parties said Thursday they plan to craft legislation to give the FDA authority over compounding pharmacies the agency says is needed in light of the ongoing fungal meningitis outbreak that has killed 32 people.

But what that legislation will look like and if it will even gain enough support to pass remains to be seen.

"Hopefully, we'll have something soon next year to help put this sad chapter behind us," Senate Health, Education, Labor and Pensions Committee Chair Tom Harkin (D-Iowa) said at the close of a Senate hearing examining the meningitis outbreak.

FDA Commissioner Margaret Hamburg, MD, received more harsh questions during the hearing about why her agency didn't do more to stop the New England Compounding Center (NECC) -- known by state and federal regulators to have a shaky track record -- before it shipped more than 17,000 vials of tainted methylprednisolone acetate that has sickened 461 and killed 32 since late September.

Hamburg, as she did before a House Energy and Commerce subcommittee on Wednesday, said the FDA's authority over compounding pharmacies is "limited, unclear, and contested."

While compounding pharmacies are regulated by state boards of pharmacies, manufacturing is overseen by the FDA, and the line separating the two has been blurred by court cases rejecting the agency's actions, she said. That limited authority helped the NECC sidestep FDA oversight as a manufacturer and produce contaminated products.

Now Republicans and Democrats in the Senate say the FDA needs power over compounders that clearly mass-produce drugs in advance for bulk shipping.

"We don't need to disturb the local drugstores and we don't need to do more about the big manufacturers," Sen. Lamar Alexander (R-Tenn.) told MedPage Today on Thursday. "We need to make sure that when a hospital in Tennessee buys a steroid that it buys it from a manufacturer that is regulated by the FDA, or it buys it from a pharmacy that is properly regulated."

Traditional compounders, who generally operate under the one-prescription-one-drug paradigm, will still be under the oversight of state boards of pharmacies. Nontraditional compounders would register with the FDA and adhere to other requirements typically mandated for manufacturers.

The FDA's approach is far too complicated, one pharmacy trade group said.

"When we start with these tiers and these additional hybrids, I am very concerned," David Miller, RPh, chief executive of the International Academy of Compounding Pharmacists, told senators. "The more complex we make this and the more we get into the shuffle between who is accountable ... we will not resolve this problem. Either you are a pharmacy or you are a manufacturer."

Sen. Pat Roberts (R-Kan.) took particular interest in Thursday's hearing, having supported an amendment to the 1997 FDA Modernization Act that would have allowed the FDA a closer look at regulated compounded pharmacies. That language was stripped from a final bill.

Implementing criteria to determine whether companies should be regulated by states or by the FDA

Requiring adverse event reporting for compounding pharmacies

Labeling compounded products as such

Marion Kainer, MD, director of healthcare associated infections at the Tennessee Department of Health, told senators Thursday that some providers in the current outbreak believed they were buying steroids from a manufacturer and not a compounder because products weren't labeled as being compounded.

The bipartisan push for some sort of legislation in the Senate was not as unanimous in the House during Wednesday's hearing.

While House Democrats were pushing for legislation even as soon as next month, their Republican counterparts said they believe the FDA had all the authority it needed to prevent the NECC and the meningitis outbreak. However, some were open to the idea of legislation if the FDA can prove where its authority is lacking.

Lawmakers from both parties and in both chambers criticized the FDA and the Massachusetts Department of Public Health over the 2 days of hearings for not doing more to stop the NECC, which has been known since at least 2002 to be mass-producing drugs in unsanitary conditions.

The FDA said that in the 1997 FDA Modernization Act, Congress exempted compounders from the agency's purview, and efforts to regulate them have been blocked by various federal circuit courts.

Senators requested documents from the FDA, NECC, and Massachusetts health officials in their investigation, and received 10,000 pages summarizing the near decade-long relationship between NECC and regulators.

"There were a number of authorities and mechanisms for both federal and state regulators to address this issue, but bureaucratic inertia appears to be what allowed a bad actor to repeatedly risk public health," the report concluded.

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